Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia (STEP 203)

Otsuka

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: OPC-34712; Drug: Aripiprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905307

331-07-203

Details and patient eligibility

About

This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.

Enrollment: 459 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
3. Subjects experiencing an acute exacerbation of psychotic symptoms

Exclusion criteria

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug

2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

   • Schizoaffective disorder
   • MDD
   • Bipolar disorder
   • Delirium, dementia, amnestic or other cognitive disorder
   • Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder

3. Subjects presenting with a first episode of schizophrenia

4. Other protocol specific inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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459 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

OPC-34712 0.25 mg arm

Treatment:

Drug: OPC-34712

2

Experimental group

Description:

OPC-34712 low-dose arm

Treatment:

Drug: OPC-34712

3

Experimental group

Description:

OPC-34712 mid-dose arm

Treatment:

Drug: OPC-34712

4

Experimental group

Description:

OPC-34712 high-dose arm

Treatment:

Drug: OPC-34712

5

Placebo Comparator group

Treatment:

Drug: Placebo

6

Active Comparator group

Description:

Aripiprazole arm

Treatment:

Drug: Aripiprazole